hemoblast pilot clinical investigation

Conditions: Hemostasis

Summary: the primary objective of this pilot clinical investigation is to assess the reliability of the surface bleeding severity scale (sbss) in a clinical setting. secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of hemoblast™ bellows in abdominal and orthopedic lower extremity surgeries.

hemoblast™ bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical. this is a prospective, multicenter, single-arm pilot clinical investigation. there will be 36 subjects enrolled across 4 investigational sites. the subjects will be followed at hospital charge and 6 weeks postoperatively. the primary endpoint of this clinical investigation is the mean paired kappa statistic for the assignment of sbss scores by 2 investigators. secondary endpoints of this clinical investigation consist of: * proportion of subjects achieving hemostasis within 6 minutes of hemoblast™ bellows application; * proportion of subjects achieving hemostasis within 10 minutes of hemoblast™ bellows application; * proportion of subjects achieving hemostasis within 3 minutes of hemoblast™ bellows application; and * incidence of adverse events through final follow-up.

Eligibility criteria:
inclusion criteria: * • subject is undergoing an elective open abdominal or orthopedic lower extremity surgery; * subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation; * subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and * subject is 21 years of age or older. * subject does not have an active or suspected infection at the surgical site; * subject in whom the investigator is able to identify a target bleeding site (tbs) for which any applicable conventional means for achieving hemostasis are ineffective or impractical; and * subject has a tbs with an sbss score of 1, 2, or 3. exclusion criteria: * • subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure; * subject is undergoing a spinal surgical procedure; * subject is undergoing a neurologic surgical procedure; * subject is undergoing an emergency surgical procedure; * subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; * subject has a clinically significant coagulation disorder or disease, defined as a platelet count \ 1.5 within 4 weeks of surgery; * subject had chronic corticosteroid use within 2 weeks prior to surgery; * subject receiving intravenous heparin or oral coumadin within 24 hours of surgery; * subject has an active or suspected infection at the surgical site; * subject has had or has planned any organ transplantation; * subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent; * subject has asa classification of \> 4; * subject has a life expectancy of less than 3 months; * subject has a known psychiatric disorder, which in the opinion of the principal investigator, would preclude the subject from completing this clinical study; * subject has a documented severe congenital or acquired immunodeficiency; * subject has religious or other objections to porcine or bovine components; * subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint implant; * subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and * subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the principal investigator.